Endoscopic device and system

ABSTRACT

An endoscopic system may include a catheter or tubing and at least one optical sensor disposed along the catheter or tubing and configured to capture image information from a body lumen when disposed within the body lumen and activated. The system may further include an untethered module operatively arranged with the at least one optical sensor and configured to store or transmit image information captured by the at least one optical sensor. The catheter or tubing, at least one optical sensor and module may be portable during use.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of application Ser. No. 13/071,937,filed Mar. 25, 2011, which claims the benefit of U.S. ProvisionalApplication No. 61/321,911, filed Apr. 8, 2010, each of which is herebyincorporated by reference in its entirety.

BACKGROUND

Sleep disordered breathing, including snoring and obstructive sleepapnea, affects tens of millions of adults in the United States. It isassociated with substantial cardiovascular morbidity and mortality,endocrine disturbances, excessive daytime sleepiness, quality of lifeand performance deficits, and motor vehicle crashes.

Treatment options include behavioral measures such as weight loss,positive airway pressure therapy, surgery, and oral appliances. Alltreatments have strengths and weaknesses, and in particular surgicaltreatment has outcomes that vary widely among patients and procedures.

The evaluation of patients with sleep disordered breathing may improveoutcomes of surgical treatment. The goals of such evaluation includecharacterizing (1) the pattern of airway obstruction (involvingprimarily the palate/tonsils region, tongue base, epiglottis, and/orlateral pharyngeal walls) and (2) the site of sound production. Existingupper airway examination techniques, however, may not provide anaccurate evaluation of the pharynx during natural sleep as explainedbelow.

A flexible endoscope such as the Olympus fiberscope or the Olympus videoscope may be utilized to examine a patient's upper airway duringwakefulness, natural sleep or sedation. Examination during natural sleepmay provide the best results, but attempts to perform traditionalnatural sleep endoscopy have been largely abandoned for multiplereasons, including the fact that it requires that an operator be presentto hold the endoscope in place during the often prolonged period neededfor patients to fall asleep with the endoscope in place. The behavior ofthe upper airway during wakefulness differs dramatically compared tonatural sleep, which makes examinations during wakefulness insufficient.Sedation is costly because it requires a controlled environment and theinvolvement of highly trained personnel and specialized equipment. Inaddition, sedation may alter the pattern of upper airway obstruction.

Current examinations during wakefulness, sedation, and natural sleep arealso limited because their duration is typically no more than 10-15minutes due to personnel and financial constraints. It is unclearwhether this abbreviated examination adequately describes pharyngealbehavior through an entire night of sleep.

There is enthusiasm among clinicians and patients alike for improvedsurgical evaluation techniques, particularly techniques that provide anaccurate, dynamic assessment of the upper airway during natural sleepwithout the need for sedation, the presence of a clinician, or theassociated costs.

SUMMARY

An endoscopic device may include a catheter or tubing and at least twooptical sensors spaced apart from each other along the catheter ortubing such that, for example, image information from different regionsof a body lumen partially or completely separated by an obstruction iscaptured when each of the at least two optical sensors is disposedwithin one of the regions and activated.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic diagram of an endoscopic system.

FIG. 2 is a schematic diagram of another endoscopic system.

FIG. 3 is a schematic diagram of a data and/or power module of anendoscopic system.

FIG. 4 is a schematic diagram of the sensor arrangement of theendoscopic system of FIG. 1.

FIG. 5 is a schematic diagram of another sensor arrangement for anendoscopic system.

FIG. 6 is a schematic diagram of yet another sensor arrangement for anendoscopic system.

FIG. 7A is a perspective view of one of the optical sensors of theendoscopic system of FIG. 1.

FIG. 7B is a side view, in cross-section, of the optical sensor of FIG.7A.

FIG. 8A is a perspective view of another optical sensor of an endoscopicsystem.

FIG. 8B is a side view, in cross-section, of the optical sensor of FIG.8A.

FIGS. 9A and 9B are front and rear schematic views, respectively, of theendoscopic system of FIG. 2 fitted to a patient's head in the in-useposition.

FIGS. 10A and 10B are side views, in sagittal cross-section, of thepatient's head and optical sensor arrangement of FIGS. 9A and 9B.

FIGS. 11A and 11B are front and rear schematic views, respectively, ofanother embodiment of an endoscopic system fitted to a patient's head inthe in-use position.

FIGS. 12A and 12B are front and rear schematic views, respectively, ofyet another endoscopic system fitted to a patient's head in the in-useposition.

DETAILED DESCRIPTION

As required, detailed embodiments of the present invention are disclosedherein; however, it is to be understood that the disclosed embodimentsare merely exemplary of the invention that may be embodied in variousand alternative forms. The figures are not necessarily to scale; somefeatures may be exaggerated or minimized to show details of particularcomponents. Therefore, specific structural and functional detailsdisclosed herein are not to be interpreted as limiting, but merely as arepresentative basis for teaching one skilled in the art to variouslyemploy the present invention.

Referring to FIG. 1, an embodiment of an endoscopic system 10 may beused to collect visual and/or audio information from a patient's airway.This information may be displayed and/or played by the output system 12.The endoscopic system 10 may include an optical sensor arrangement 14, adata and/or power module 16, a sensor cord 18 connecting the sensorarrangement 14 and module 16, and a skullcap 19. Other arrangements arealso possible and will be discussed in further detail below.

The module 16 may be removably attached with the skullcap 19 via VELCRO,a snap feature or other suitable attachment mechanism. The skullcap 19may include an elastic band 20 configured to secure the skullcap 19 andsensor cord 18 to a patient's head.

The sensor arrangement 14, in the embodiment of FIG. 1, includes a bodyportion 21 and a pair of legs 22 of differing lengths projecting therefrom. Each of the legs 22 has an optical sensor 24 disposed at an endthereof. The sensor arrangement 14 also includes a connector 26 (e.g., aUSB port, a fiber optic connector, etc.) disposed at an end of the bodyportion 21 opposite the legs 22 and capable of, for example, connectingthe optical sensors 24 with a mating connector 28 of the sensor cord 18and/or a mating connector 30 of the display system 12.

When the sensor arrangement 14 is connected with the module 16, themodule 16 may store information received from the sensor arrangement 14for later access. For example, the module 16 may store collectedinformation while a patient is asleep. An investigator may then accessthe stored information at a later time. When the sensor arrangement 14is connected with the display system 12, information captured by thesensor arrangement 14 may be viewed in real-time.

The display system 12 may include a display screen 32 and anysuitable/known decoder device 34 (e.g., a non-wearable version of module16, a video monitor, a smart phone, a personal computer with suitablehardware/software, etc.) The decoder device 34 may be configured tointerpret information from the sensor arrangement 14 and generateappropriate signals for (i) display and/or play by the display screen 32and/or (ii) data storage in a storage device (not shown).

Referring to FIG. 2, the sensor arrangement 114 is directly connectedwith the module 116. The module 116 may wirelessly transmit (and/orstore) information from the sensor arrangement 114 to the decoder device134 for real-time display and/or play. Other arrangements are, ofcourse, also possible. For example, the module 116 may wirelesslytransmit information from the sensor arrangement 114 to a remote storagedevice (not shown). Alternatively, the module 116 may store theinformation from the sensor arrangement 114 for later access, etc.

Referring to FIG. 3, an embodiment of a data and/or power module 216 mayinclude a bundle coupling 236, a microphone input 238, a microprocessor240, a memory 242 (e.g., a card reader, etc.), and a radiofrequencytransmitter 244 all mounted on a printed circuit board 246. The module216 may also include a rechargeable power source 250 (e.g., rechargeablebatteries) disposed, in this embodiment, on a side of the circuit board246 opposite the microprocessor 240, and various switches 252 (e.g., apower switch, a microphone switch, etc.) The coupling 236 may include arecharging port 248, image sensors 254, and associated LEDs 256. Hence,the module 216 is self-contained and may operate untethered. That is, itmay operate without being attached via cording to a separate powersource, processor, memory, etc. (unlike certain conventionalarrangements).

In other embodiments, the image sensors 254, for example, may bereplaced with suitable connectors for cameras; the transmitter 244 maybe replaced with a suitable wired data output, etc.

Information received via the coupling 236 and/or the microphone input238 may be processed by the microprocessor 240 in any suitable/knownfashion and stored in the memory 242 and/or wirelessly transmitted viathe radiofrequency transmitter 244.

Referring to FIG. 4, the sensor arrangement 14 of FIG. 1 is shown infurther detail. The legs 22 are of different lengths such that theoptical sensor 24 disposed at the end of the longer leg 22 may captureimages from an area of a patient's airway different than the imagescaptured by the optical sensor 24 disposed at the end of the shorter leg22. Given this arrangement, different regions within the airway may beobserved at the same time, even if there is an intervening structurethat obstructs the simultaneous visualization of both (or all) areaswith a single optical sensor. For snoring and sleep apnea, as anexample, the soft palate can isolate two areas of the airway (above andbelow) if it completely or partially obstructs the airway. The use oftwo cameras or other methods of image acquisition from two sites (asopposed to one) enables the simultaneous visualization of the two areas.

In the embodiment of FIG. 4, the optical sensors 24 are spaced apart ata distance that may be greater than or equal to 5 mm. That is, thelength of the longer leg 22 may be at least 5 mm greater than that ofthe shorter leg 22. In other embodiments, the optical sensors 24 may bespaced at any distance suitable for capturing images of differentregions of a patient's airway (e.g., 5 mm, 10 mm, 50 mm, etc.)

Some embodiments may have more or less than two legs 22 and twoassociated optical sensors 24. For example, a sensor arrangement mayhave three legs each with an optical sensor disposed at an end thereof.The number of legs (and thus the number of optical sensors) may,however, be limited by the effective diameter of a patient's airway.

Referring to FIG. 5, the legs 322 of the sensor arrangement 314 have thesame or different lengths, but a clamp 358 (band, locking mechanism,etc.) may be used to effectively change the length of one of the legs322 relative to the other. This arrangement may be used to tailor thedistance between the optical sensors 324 for a particular patient whileusing a standard sensor arrangement.

Referring to FIG. 6, the optical sensors 424 are disposed (and spacedapart) along the body portion 421 of the sensor arrangement 414. Thisarrangement, relative to the embodiments of FIGS. 4 and 5, may allow thepackaging of several of the optical sensors 424 without substantiallyaltering the diameter of the sensor arrangement 414.

Referring to FIGS. 7A and 7B, one of the optical sensors 24 of FIG. 1 isshown in further detail. In this embodiment, the optical sensor 24includes a camera 60 and associated lens 62. The camera 60 may receivepower from and transmit image information to the module 16 of FIG. 1 viaelectrical/communication lines 64. Illumination fibers 66 in opticalcommunication with, for example, LEDs within the module 16 of FIG. 1 aredisposed within the leg 22. The illumination fibers 66 provide light forthe camera 60.

The optical sensor 24 may have a diameter ranging from approximately 6mm to 10 mm. The leg 22 may have a diameter ranging from approximately 2mm to 5 mm. Other diameters and sizes, however, are also possibledepending on, for example, camera size, fiber diameter, etc.

Referring to FIGS. 8A and 8B, another embodiment of an optical sensor524 is shown in further detail. The optical sensor 524 includes a videofiber optic element 568 and associated lens 562. Because the opticalsensor 524 does not include an internal camera (similar to the opticalsensor 24 of FIGS. 7A and 7B), its diameter may range in size fromapproximately 3 mm to 8 mm. Other diameters and sizes, however, are alsopossible depending on, for example, fiber diameter, etc. In otherembodiments, any suitable/known optical sensor may be used.

Referring to FIGS. 9A, 9B, 10A and 10B, the endoscopic system 110 ofFIG. 2 is fitted to a patient's head. The sensor arrangement 114 ispositioned such that the optical sensors 124 capture image informationfrom different regions within the patient's airway. More specifically,the legs 122 are arranged and the optical sensors 124 are positioned, inthis example, such that the optical sensors 124 capture imageinformation from the retropalatal and retrolingual regions of thepatient's pharynx regardless of whether there is an obstruction betweenthe two regions (e.g., the soft palate obstructing the airway, as inFIG. 10B). The sensor arrangement 114 may also be arranged, of course,to capture, for example, image information from a single region ormultiple overlapping or non-overlapping regions of any body lumen.

The skullcap 119 is placed over the patient's head and the module 116 isattached thereto with, for example, a snap feature (not shown). The bodyportion 121 is attached to the patient's cheek and nose with adhesive170. This arrangement may permit the patient to wear (attended orunattended) the endoscopic system 110 for extended periods of time whileimage information from their airway is collected and, for example,stored within the module 116.

Referring to FIGS. 11A and 11B, another embodiment of an endoscopicsystem 610 is fitted to a patient's head. In this embodiment, theheadband 620 is larger than in the embodiments of, for example, FIGS. 1and 2. Hence, the module 616 may be attached directly to the front ofthe headband 620 (or the rear/side as desired).

Referring to FIGS. 12A and 12B, yet another embodiment of an endoscopicsystem 710 is fitted to a patient's head. The headband 720, in thisembodiment, encompasses the nose of the patient and provides a harnessin the rear where the module 716 may be attached. In this embodiment,the body portion 721 need not be attached directly to the patient'sface. Rather, the body portion 721 is attached to the headband 720 viasnaps 772 or other suitable attachment features. Other arrangements arealso possible.

While embodiments of the invention have been illustrated and described,it is not intended that these embodiments illustrate and describe allpossible forms of the invention. Rather, the words used in thespecification are words of description rather than limitation, and it isunderstood that various changes may be made without departing from thespirit and scope of the invention. As an example, certain embodimentsmay be used to collect images over a period of time from any body lumen(e.g., nasal cavity, esophagus, stomach, small intestine and largeintestine, etc.) As another example, while endoscopic systems includingeither an internal (to the body) camera with an external light sourceand battery or an external camera, light source and battery have beenexplicitly disclosed, other embodiments of endoscopic systems mayinclude an internal camera, battery and light source, an internal cameraand light source with an external battery, an internal camera andbattery with an external light source, or any other internal/externalcombination of components. As yet another example, certain embodimentsmay be fitted to any part of a patient's body via suitablecuffs/adhesives/bands/pockets/etc.

1-11. (canceled)
 12. A method for examining an airway of a human patientcomprising: inserting into a nasal cavity of the patient an endoscopicdevice including a catheter or tubing and at least two optical sensorsattached to the catheter or tubing; and positioning the catheter ortubing in a retropalatal or retrolingual region of an upper airway ofthe patient but not in an esophagus of the patient such that the atleast two optical sensors are spaced away from each other along thecatheter or tubing and that image information from each of theretropalatal region and retrolingual region is captured when the atleast two optical sensors are activated.
 13. The method of claim 12further comprising: removably but fixably securing a portion of thecatheter or tubing to a body of the patient.
 14. The method of claim 12further comprising: operatively arranging the endoscopic device with anuntethered module configured to store or transmit wirelessly imageinformation captured by the at least two optical sensors, wherein thecatheter or tubing, at least two optical sensors and module are portableduring use.
 15. The method of claim 12 further comprising: operativelyarranging the endoscopic device with an untethered module including atleast one of a power source, memory, transmitter, microphone andillumination source.
 16. The method of claim 12 further comprising:operatively arranging the endoscopic device with an untethered moduleand a band or cuff attachable with the module and configured to securethe module to a body of the patient.
 17. A method for examining anairway of a human patient comprising: inserting into a nasal cavity ofthe patient an endoscopic device including a catheter or tubing and atleast one optical sensor attached to the catheter or tubing; andpositioning the catheter or tubing in a retropalatal or retrolingualregion of an upper airway of the patient but not in an esophagus of thepatient such that image information from the retropalatal region orretrolingual region is captured when the at least one optical sensor isactivated; and removably but fixably securing a portion of the catheteror tubing to a body of the patient.
 18. The method of claim 17 furthercomprising: operatively arranging the endoscopic device with anuntethered module configured to store or transmit wirelessly imageinformation captured by the at least one optical sensor, wherein thecatheter or tubing, at least one optical sensor and module are portableduring use.
 19. The method of claim 17 further comprising: operativelyarranging the endoscopic device with an untethered module comprising atleast one of a power source, memory, transmitter, microphone andillumination source.
 20. The method of claim 17 further comprising:operatively arranging the endoscopic device with an untethered moduleand a band or cuff attachable with the module and configured to securethe module to the body.
 21. A method for examining a human patientcomprising: inserting into a hollow body cavity of the patient anendoscopic device including a catheter or tubing having at least twobranches of unequal length extending from a common joint, each of thebranches having an optical sensor attached thereto; positioning thebranches within the cavity such that the at least two optical sensorsare spaced away from each other and that image information fromdifferent regions of the cavity is captured when the at least twooptical sensors are activated; and removably but fixably securing aportion of the catheter or tubing to a body of the patient.
 22. Themethod of claim 21 further comprising: operatively arranging theendoscopic device with an untethered module configured to store ortransmit wirelessly image information captured by the at least twooptical sensors, wherein the catheter or tubing, at least two opticalsensors and module are portable during use.
 23. The method of claim 21further comprising: operatively arranging the endoscopic device with anuntethered module including at least one of a power source, memory,transmitter, microphone and illumination source.
 24. The method of claim21 further comprising: operatively arranging the endoscopic device withan untethered module and a band or cuff attachable with the module andconfigured to secure the module to the body.
 25. A method for examininga human patient comprising: inserting into a hollow body cavity of thepatient an endoscopic device including a catheter or tubing and at leastone optical sensor attached to the catheter or tubing; positioning thecatheter or tubing such that image information from the at least oneoptical sensor is captured when the at least one optical sensor isactivated; and removably but fixably securing a portion of the catheteror tubing to a body of the patient.
 26. The method of claim 25 furthercomprising: operatively arranging the endoscopic device with anuntethered module configured to store or transmit wirelessly imageinformation captured by the at least one optical sensor, wherein thecatheter or tubing, at least one optical sensor and module are portableduring use.
 27. The method of claim 25 further comprising: operativelyarranging the endoscopic device with an untethered module including atleast one of a power source, memory, transmitter, microphone andillumination source.
 28. The method of claim 25 further comprising:operatively arranging the endoscopic device with an untethered moduleand a band or cuff attachable with the module and configured to securethe module to the body.